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NCT01890265 · ClinicalTrials.gov registry record · Phase 2
Evaluate the Safety and Efficacy of FG-3019 (Pamrevlumab) in Participants With Idiopathic Pulmonary Fibrosis (IPF)
A Phase 2 study, sponsored by Kyntra Bio.
- Completed
- Registry status
- Phase 2
- Development phase
- 160
- Enrollment target
NCT01890265: Completed Phase 2 study, sponsored by Kyntra Bio.
NCT01890265 is a Phase 2 study that has completed, run by Kyntra Bio. The registered enrollment target is 160 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01890265, a Phase 2 study, has completed, sponsored by Kyntra Bio.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 160 participants
- Enrollment target
Study Summary
To evaluate the safety and tolerability of pamrevlumab in participants with IPF, and the efficacy of pamrevlumab in slowing the loss of forced vital capacity (FVC) and the progression of IPF in these participants.
Primary Outcome
FVC in liters was measured during the spirometry assessments at screening and during the randomized treatment period at Day 1 and every 12 weeks. The FVC (% predicted) was calculated for the corresponding gender-race-age group. The least squares (LS) mean change from Baseline to Week 48 (end of the randomized treatment period) in FVC (% predicted) is presented. Baseline was defined as the mean of the last screening visit and the Day 1 visit values. Other statistical analysis data is reported in
Interventions
- DRUG Placebo
- DRUG Pamrevlumab
- DRUG Sub-Study: Pirfenidone
- DRUG Sub-Study: Nintedanib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 160 participants |
| Start Date | 2013-07-30 |
| Est. Completion | 2017-11-16 |
| Phase | Phase 2 |
What the finished NCT01890265 record still lists
NCT01890265 is an interventional study that assigns participants to a tested intervention. The registered 160 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (20% higher).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01890265 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01890265 about?
NCT01890265 is a clinical study titled "Evaluate the Safety and Efficacy of FG-3019 (Pamrevlumab) in Participants With Idiopathic Pulmonary Fibrosis (IPF)". To evaluate the safety and tolerability of pamrevlumab in participants with IPF, and the efficacy of pamrevlumab in slowing the loss of forced vital capacity (FVC) and the progression of IPF in these participants.
What is the current status of trial NCT01890265?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 160 participants. The study started on 2013-07-30. Estimated completion is 2017-11-16.
What interventions are being tested in trial NCT01890265?
The interventions under investigation include: Placebo (DRUG), Pamrevlumab (DRUG), Sub-Study: Pirfenidone (DRUG), Sub-Study: Nintedanib (DRUG).
Who is sponsoring clinical trial NCT01890265?
This trial is sponsored by Kyntra Bio, which has 30 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01890265's enrollment target sits among peer trials
160 422nd of 2000 higher than 1,559 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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